A Multi-Center, Open-Label, Single-Arm, Phase 2 Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Vabomere (Meropenem-Vaborbactam) In The Treatment Of Children With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 66
- 试验地点
- 50
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
The primary objective of the study is to assess the safety and tolerability of meropenem-vaborbactam administered by intravenous (IV) infusion in children 3 months and above to less than 12 years with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a clinically suspected and/or bacteriologically documented cUTI or AP judged by the Investigator to require hospitalization for treatment with at least 3 days of IV antibiotics.
- •Evidence of pyuria, confirmed by either of the following:
- •A urine specimen that is positive for leukocyte esterase via urine dipstick or urinalysis, or
- •A urine specimen with either > 10 white blood cells (WBCs) per microliter from an unspun urine or > 5 WBCs per high power field from a centrifuged specimen
- •Symptomatic or asymptomatic cUTI or AP as specified in the protocol.
- •Acute Pyelonephritis (qualifying symptoms specified in protocol).
- •Have a pretreatment "baseline" urine specimen obtained for culture by an acceptable method, including suprapubic aspiration (SPA), clean urethral catheterization, in dwelling urethral catheter, or mid-stream clean catch (urine specimens obtained from externally placed urine bags will not be allowed) within 48 hours before the start of the administration of the first dose of IV study drug therapy.
- •Must, based on the judgment of the Investigator, require hospitalization initially and 7 to14 days of antibacterial therapy for the treatment of the presumed cUTI.
排除标准
- •History of hypersensitivity or allergic reaction to beta-lactam antibiotics (for example [e.g.], cephalosporins, penicillins, carbapenems, monobactams).
- •Known Vabomere-resistant gram-negative organism from study-qualifying urine or blood culture, confirmed cUTI or AP only due to gram-positive organism from study-qualifying urine or blood culture, or known or suspected infection with organisms that are not adequately covered by Vabomere (e.g., viral, mycobacterial, fungal).
- •Receipt of a potentially effective antibacterial drug therapy for cUTI for a duration of more than 24 hours during the previous 72 hours prior to enrollment. Exceptions: participants with unequivocal clinical evidence of treatment failure (that is, worsening signs and symptoms); urine culture confirms resistance to the initial antibiotic; or the participant developed signs and symptoms of cUTI or AP while on antibiotics for another indication.
- •Participants undergoing dialysis or with estimated glomerular filtration rate (eGFR) < 30 mL/minute/1.73 m^2, as calculated using the updated bedside Schwartz formula.
- •Evidence of significant hepatic disease or dysfunction, including known acute viral or inactive chronic hepatitis or hepatic encephalopathy, or aspartate aminotransferase or alanine aminotransferase > 3 × upper limit normal (ULN), or total bilirubin > 1.5 × ULN.
- •Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Cohort 1: Age 6 to < 12 years
Participants will receive meropenem-vaborbactam via an IV infusion for a minimum of 3 days, for up to 14 days.
Participants with clinical improvement have the option to switch to an oral antibiotic or home IV therapy after Day 3.
干预措施: Antibiotics (Drug)
Cohort 1: Age 6 to < 12 years
Participants will receive meropenem-vaborbactam via an IV infusion for a minimum of 3 days, for up to 14 days.
Participants with clinical improvement have the option to switch to an oral antibiotic or home IV therapy after Day 3.
干预措施: Meropenem-Vaborbactam (Drug)
Cohort 2: Age 2 to < 6 years
Participants will receive meropenem-vaborbactam IV infusion for a minimum of 3 days, for up to 14 days.
Participants with clinical improvement have the option to switch to an oral antibiotic or home IV therapy after Day 3.
干预措施: Antibiotics (Drug)
Cohort 3: Age 3 months to < 2 years
Participants will receive meropenem-vaborbactam IV infusion for a minimum of 3 days, for up to 14 days.
Participants with clinical improvement have the option to switch to an oral antibiotic or home IV therapy after Day 3.
干预措施: Meropenem-Vaborbactam (Drug)
Cohort 3: Age 3 months to < 2 years
Participants will receive meropenem-vaborbactam IV infusion for a minimum of 3 days, for up to 14 days.
Participants with clinical improvement have the option to switch to an oral antibiotic or home IV therapy after Day 3.
干预措施: Antibiotics (Drug)
Cohort 2: Age 2 to < 6 years
Participants will receive meropenem-vaborbactam IV infusion for a minimum of 3 days, for up to 14 days.
Participants with clinical improvement have the option to switch to an oral antibiotic or home IV therapy after Day 3.
干预措施: Meropenem-Vaborbactam (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Up to 28 days
次要结局
- Maximum Observed Plasma Concentration (Cmax)(Day 1 and Day 3: Up to 3 hours post-dose)
- Time to Maximum Observed Plasma Concentration (Tmax)(Day 1 and Day 3: Up to 3 hours post-dose)
- Overall Response (OR)(Up to 14 days)
- Clinical Cure(Up to 14 days)
- Favorable Microbiological Response (Microbiological Eradication)(Up to 14 days)
- Maximum Observed Plasma Concentration (Cmax)(Day 1 and Day 3: Up to 3 hours post-dose)
- Time to Maximum Observed Plasma Concentration (Tmax)(Day 1 and Day 3: Up to 3 hours post-dose)
- Area Under the Plasma Concentration Curve from Zero to Infinity (AUC0-inf)(Day 1 and Day 3: Up to 3 hours post-dose)
- Overall Response (OR)(Up to 14 days)
- Clinical Cure(Up to 14 days)
- Favorable Microbiological Response (Microbiological Eradication)(Up to 14 days)